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NCT Number: NCT03844360

Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease

The investigators' purpose was to assess the feasibility of dosage individualization of the commonly used antineoplastic drugs and anti-infective drugs in children with hematoplastic disease.

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Key information

Conditions

Hematological Neoplasms Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Pediatrics, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China

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About this study

The investigators' purpose was to assess the feasibility of dosage individualization of the commonly used antineoplastic drugs and anti-infective drugs based on the opportunistic sampling strategy in children with confirmed or suspected hematological neoplasms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must be diagnosed with hematological neoplasms
  • Antineoplastic drugs or anti-infective drugs used as part of regular treatment

Exclusion criteria

  • expected survival time less than the treatment cycle;
  • patients with other factors that researcher considers unsuitable for inclusion.

Treatment and study plan

bortezomib

Drug

bortezomib was administered follow the doctor's advice.

Other names: Velcade

eltrombopag

Drug

eltrombopag was administered follow the doctor's advice.

Other names: promacta

Imatinib

Drug

imatinib was administered follow the doctor's advice.

Other names: Gleevec

dasatinib

Drug

dasatinib was administered follow the doctor's advice.

Other names: sprycel

pegaspargase

Drug

pegaspargase was administered follow the doctor's advice.

Other names: Oncaspar

Anti-Infective Drugs

Drug

anti-infective drugs was administered follow the doctor's advice.

PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor

Drug

pegaspargase was administered follow the doctor's advice.

Other names: PEG-rhG-CSF

Primary outcomes

  1. change of plasma concentration of bortezomib

    Time frame: at(0-0.5)h,(0.5-3)h,(24-48)h,(48-72)h hours after administration

    To detect the plasma concentrations of bortezomib after administration

  2. change of plasma concentration of eltrombopag

    Time frame: at (0.5-3)h,(3-6)h,(10-14)h,(20-24)h hours after oral administration

    To detect the plasma concentrations of eltrombopag after administration

  3. change of plasma concentration of imatinib

    Time frame: at (0.5-2)h,(2-4)h,(10-14)h,(20-24)h hours after oral administration

    To detect the plasma concentrations of imatinib after administration

  4. change of plasma concentration of dasatinib

    Time frame: at(0-0.5)h,(0.5-3)h,(10-14)h,(20-24)h hours after oral administration

    To detect the plasma concentrations of dasatinib after administration

  5. change of plasma concentration of pegaspargase

    Time frame: at Day-1,Day(0-1),Day(3-5),Day(8-10),Day(13-14) after administration

    To detect the plasma concentrations of pegaspargase after administration

  6. plasma concentration of anti-infective drug

    Time frame: through study completion, an average of 14 days

    To detect the plasma concentrations of anti-infective drug after administration

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Zhao, Ph.D

CONTACT

[email protected]

86053188383308

Yan H Shi, Ph.D

CONTACT

[email protected]

86053188383308

Sponsors and collaborators

Lead sponsor

Wei Zhao

Other

Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Registry information

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Feb 18, 2019
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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